Article(id=1236331740348871637, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331736221676464, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1686672000000, acceptedDateStr=2023-06-14, onlineDate=1772694056832, onlineDateStr=2026-03-05, pubDate=1699977600000, pubDateStr=2023-11-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694056832, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694056832, creator=13701087609, updateTime=1772694056832, updator=13701087609, issue=Issue{id=1236331736221676464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='21', pageStart='2121', pageEnd='2224', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694055848, creator=13701087609, updateTime=1772696903836, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236343681607856366, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331736221676464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236343681607856367, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331736221676464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2218, endPage=2224, ext={EN=ArticleExt(id=1236331740634084319, articleId=1236331740348871637, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Determination of nitrite ion in rifampicin and rifapentine capsules by solid phase extraction-ion chromatography, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: Different levels of genotoxic impurities 1-methyl-4-nitroso piperazine (MNP) and 1-methyl-4-nitroso piperazine (CPNP) were detected in rifampicin and rifapentine capsules. In this study, the nitrite ions in rifampicin and rifapentine capsules were determined by solid phase extraction-ion chromatography to explore the relationship between the content of nitrite ions and the formation of above genotoxic impurities.
Methods: The method of solid phase extraction-ion chromatography used for nitrite determination was established and validated.
Results: Nitrite ion was not detected in rifampicin and rifapentine capsules with different levels of MNP and CPNP.
Conclusion: It is speculated that the origin of MNP and CPNP in rifampin and rifapentine capsules was not from nitrite ion, but derived from oxidative degradation of API.
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目的： 在利福平、利福喷丁胶囊中检测出含量不同的遗传毒性杂质1-甲基-4-亚硝基哌嗪（MNP）、1-环戊基-4-亚硝基哌嗪（CPNP），本研究用固相萃取-离子色谱法对利福平、利福喷丁胶囊中的亚硝酸根离子进行测定，探究亚硝酸根离子含量与遗传毒性杂质MNP，CPNP形成的关系。
方法： 建立了固相萃取-离子色谱法对亚硝酸根离子测定，并完成了方法验证。
结果： 含有不同MNP，CPNP含量的利福平、利福喷丁胶囊中均未检出亚硝酸根离子。
结论： 利福平、利福喷丁胶囊中MNP，CPNP的产生与亚硝酸根离子无关，其可能是利福平、利福喷丁氧化降解产物。
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崇小萌，女，主任药师，主要从事药物质量分析控制研究。
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, authorsList=田冶, 冯媛媛, 陶晓莎, 姚尚辰, 崇小萌, 尹利辉)}, authors=[Author(id=1236331741326143489, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331740348871637, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=tianye95950@163.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236331741447778312, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331740348871637, authorId=1236331741326143489, language=EN, stringName=Ye TIAN, firstName=Ye, middleName=null, lastName=TIAN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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田冶，男，研究员，主要从事抗生素质量分析工作。联系电话：(010)53851533，E-mail: tianye95950@163.com。
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冯媛媛，女，硕士研究生，主要从事抗生素质量控制研究。E-mail: yyuan399@163.com。
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